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Senior Clinical Research Associate
2 months ago
Kelly® Science & Clinical is seeking a Senior Clinical Research Asssociate and Manager for a fulltime, direct hire position with a pharmaceutical client in New Jersey. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
No C2C
Full-time, perm, direct hire
The Clinical Research Associate (CRA) is responsible for the implementation, monitoring, and summarization of clinical trials in compliance with protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and Standard Operating Procedures (SOPs) to ensure patient safety.
Essential Responsibilities:
Serve as the primary liaison for assigned study sites, conveying project information, answering questions, and resolving site-related issues in accordance with the clinical monitoring plan
Develop a thorough understanding of study management tasks and responsibilities necessary to comply with protocol/regulatory requirements and applicable SOPs
Attend Investigator Meetings and study-specific training for assigned trials
Have comprehensive knowledge of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites
Complete pre-study qualification visits, site initiation visits, routine monitoring, and close-out visits within established timelines, documents activities in reports in accordance with applicable SOPs and plans
Develop and maintain strong collaborative working relationships with clinical investigative sites
Ensure the trial site’s adequacy and personnel qualifications on an ongoing basis
Develop and execute corrective action plans at the site level, proportionate to the risks identified
Accountable for data integrity, patient safety, and regulatory compliance for all assigned sites
Monitor recruitment and data quality on-site and remotely through systems and communication with sites
Responsible for ongoing data review and source data verification to study-specific targets and deadlines
Collaborate with data management to plan and meet data cut and lock deadlines
Perform on-site drug accountability, reconciliation, and return when applicable
Verify that trial product receipt, handling, accounting, and storage meets protocol requirements
Assist the study team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation
Knowledge & Experience:
A minimum of 4 – 5 years of on-site monitoring experience
Recent experience with remote monitoring or risk-based monitoring preferred
A minimum of 4 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, Contract Research Organization (CRO), and/or healthcare setting preferred
Minimum of bachelor’s degree in life sciences or health-related sciences
Proficient in Microsoft Office suite (Outlook, Word, Excel, and PowerPoint); familiarity with EDC, CTMS, and document management systems
Overnight travel ranging from 30 – 80%
A core understanding of GCP as it relates to clinical trial monitoring
Demonstrate a core understanding of medical terminology and clinical trial activities in relation to the execution of a clinical development plan
Oncology experience preferred
Technical and Professional Competencies:
Excellent written and verbal communication skills; quick learner; able to handle multiple studies and aggressive timelines
Strong interpersonal skills
Seeks out opportunities to take on tasks outside of the typical CRA role when required
Great team player and comfortable working in a small company setting
Thrives in an entrepreneurial team environment
Self- Starter able to interact with global scientific, clinical, and marketing teams
Prioritizes work can rapidly respond to key stakeholders
Sense of urgency and ability to multitask in chaotic situations
Responsible and able to rapidly find solutions to issues in difficult situations
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
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